The problems of the Chinese herbal medicine industry and the fourth of solving suggestions -drink processing processing and GMP management

The problems of the Chinese herbal medicine industry and the fourth of solving suggestions -drink processing processing and GMP management

One of the articles of “Existing problems and Solutions of the Chinese Medicinal Materials Industry”, “The Professional Market of the Chinese Medicine Materials is accelerating the decline” on February 18th, and more than 40 experts were left after the article. The love and concern of the Chinese medicinal materials industry in the world will discuss with you the issues of traditional Chinese medicine decoction films and GMP today.

In recent years, the quality of Chinese medicinal materials has attracted attention from all walks of life. The quality of Chinese medicinal materials quality has affected the effects of the clinical treatment of traditional Chinese medicine. “The medicinal materials are good, the medicine is good.” The author believes that if there is no good medicinal material, it will be difficult to perform medical skills without good medicinal materials.

At present, the main links affecting the quality of Chinese medicine are planting, processing and circulation. The Chinese medicinal material drinking enterprise belonging to the processing link is currently the link of “both problems and difficulty” in the Chinese medicinal material industry chain. Why is this status quo in the Chinese medicine drinking factory?

1. Drinking production and GMP management adaptability

Traditional Chinese medicine and western medicine are two ways of thinking, which are divided into different medical systems. The author believes that the principle of traditional Chinese medicine treatment is “strong shield”, which enhances the immunity of people. The principle of the treatment of western medicine is “lingering spear”. Using the theory and method of western medicine to explain traditional Chinese medicine, some are unknown.

Figure 1. The author and the leaders of the author of Shen Shaoji and Director Wen Zaixing inspected in a Chinese medicine beverage factory

1. The cost of GMP management and production of slices

GMP is an international name for the “Specifications for Quality Management of Drug Production”. On June 18, 1999, the State Food and Drug Administration issued the “Specifications for Quality Management of Drug Production” and officially implemented from August 1, 1999. This specification is the basic criterion for drug production and quality management. It is suitable for the entire process and key processes that affect the quality of the finished product in the production of pharmaceutical preparations. The State Food and Drug Administration is responsible for certification and release.

After nearly 20 years of implementation and practice, this specification is suitable for pharmaceutical manufacturers (western medicine and Chinese medicine), which has played a key role in the improvement of drug standard production and corporate management. Sexual needs improvement.

Some traditional Chinese medicine drinking factories produce thousands of varieties and thousands of product regulations, and the processing methods of each Chinese medicinal material are different from the processing process. high pressure. The processing equipment of the medicinal materials cannot be universal. Hundreds of pharmacies and thousands of regulations are processed by one drink factory, and the cost pressure is great. This difficulty makes some of the sources of some varieties, because the cost problem is the situation of “changing the packaging” after the production area processing.

Figure 2. The processing equipment of a small and medium -sized beverage factory has basically become a decoration

Because the processing equipment of medicinal materials cannot be universal, hundreds of medicinal materials and thousands of products are processed by one drink factory by themselves. As far as the enterprise itself is concerned, the cost is not low. Only the control products and testing costs are great pressure. The varieties of DNA detection of Sichuan Fritillaria, Black Snake, and Viper; the varieties of high-efficiency liquid chromatography-mass spectrometer detection are the varieties of Sichuan dumplings, turtle shell glue, gelatin, bitter skin, antlers, thousands of miles, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment, each testing equipment. The cost is not low.

Figure 3. Different from the processing process of processing, the processing equipment of drinking can not be universal

Figure 4. Drinking factory that has passed GMP certification is expensive to test the equipment.

Figure 5. During the operation of the drinking film factory, I am afraid that the approval test is too expensive because the controlled products are too expensive.

2. Flying inspection of GMP certification of drinks

In 2014, the State Food and Drug Administration recovered 50 GMP certificates, and 20 Chinese medicine companies accounted for 40%. In 2015 , Accounted for 56.9%; 258 flight inspection in 2016, 170 GMP certificates were recovered; 157 GMP certificates were recovered in 2017; in 2018, a total of 224 GMP certificates were recovered, and 96 Chinese medicine drinking companies accounted for 43%.

3. The mode of firming and quantitative Chinese medicine with chemical composition

Traditional Chinese medicine and western medicine are like two rails of the train lane. Only in parallel can contribute to human health. Do not cross -argument. They are divided into two complete and completely different demonstration systems. Things prove that things B, using the A system to prove that the B system or comparison of each other must have their own advantages and disadvantages. Only by complement each other, recognize each other, respect each other, and avoid strengths, can we better play a role.

The so -called traditional Chinese medicine is included in the Chinese medicine theoretical system and can be used by traditional Chinese medicine theory, including Chinese medicinal materials, drinks and adults. The characteristics of western medicine are clear structure and clear pharmacological effects.

Taking the sliced ​​tablets processed by the rhizomes as an example, according to the traditional appearance classification method, some varieties should be greatly used by the film, but under the modern scientific evaluation standards of this part of the variety, “effective ingredients” are mainly distributed in the side roots and epidermis in the medicinal materials. In this case, the content of “active ingredients” with small pieces of “active ingredients” in this part of this variety is higher than that of large pieces of tablets.

4. Traditional Chinese medicine drinks and exclusive quality evaluation system

The study of modernization method mainly focuses on changes in chemical composition, with fewer research on its mechanism, and lack of standardized standardization standards. This will limit the scope of the application method to a certain extent.

The old saying goes: “Although the processing must not dare to save artificially.” However, the tedious processing process of some varieties is constantly simplified, and the medicinal materials that are not produced and processed in accordance with process regulations also appear from time to time. For example, Shouwu is a commonly used Chinese medicine in clinical practice. It was used as an auxiliary materials for the past. It pays attention to cooked and cooked. Nowadays, it is steaming with the requirements of nine steaming and nine dried sun -steaming time.

At present, some of the quality of some beverage films on the market are uneven. The author believes that the reason is that the lack of a set of easy -to -control and exclusive quality evaluation methods. Xiao Yongqing, chief researcher of the Chinese Academy of Traditional Chinese Medicine and the Director of the Quality Guarantee Specialty Committee of the Chinese Medicine Association of China, believes that it can not only rely on the shape, nor simply to judge the quality of the quality of the slices at the level of the existing known effective ingredients. The judgment standards should be organically combined to achieve the coordination and unity of the traditional hierarchical quality evaluation standards and the connotation of modern scientific quality.

Second, the processing and processing of origin and the processing of the production of the production are inseparable from the processing

The processing and processing of Chinese medicinal materials are two links in the production of traditional Chinese medicine. There is no clear division of labor between the two in history. Later, it was gradually separated into two independent segments. Storage and long -distance transportation has ignored the inherent laws of the quality of medicinal materials.

1. What is the processing of Chinese medicine materials

Traditional Chinese medicine processing is based on the theory of traditional Chinese medicine, according to the needs of the medication and the nature of the drug, and the different requirements of the doses and preparations. , Booking method, scalding, 、 method, cooking and (fire list) method, replication of fermentation method, 煨 method and frost, clean water flying method, boiled glue alchemy stone method, etc. The finished product is Chinese medicine drinking tablets.

The processing of traditional Chinese medicine drinking tablets is toxicity, the other is to increase the efficacy, and the third is to change the classics. Dry ginger, ginger, and soaking ginger are different due to different methods of making. Anyone, the master of Chinese medicine, Jin Shiyuan described the importance of the processing: “It must be planted before the medicine, and the technique of traditional Chinese medicine processing is related to the effect of medicinal effects.”

Figure 6. The master of the Chinese medicine master Jin Shiyuan took a group photo with the author when he inspected the Tiandi.com

I remember on August 22, 2015, Mr. Jin Shiyuan inspected Tiandi.com. Jin Lao’s clear thinking, knowledgeable knowledge, extraordinary memory, and strong principles left me deep memories. In the afternoon, Jin Lao insisted on inspecting the professional market of the Chinese medicinal materials in Chengdu Lotus Pond. Considering that Jin Lao was 90 years old, the author proposed to accompany the car to take care of it, but Jin Lao insisted that he only let his son accompany him, so that he did not expose it. Identity can see the real situation of the market. The attitude of Jin Lao’s responsibility for the country and the people is worthy of all our Chinese medicine people in chromium and learning!

2. Historically processing and processing is a link

The production of Chinese medicinal materials and drinking slices are two links in the production of Chinese medicine, especially the history of the origin of authentic medicinal materials. The author believes that from a historical perspective, processing and processing are basically integrated, and in history, “front room and back shop, seeing a doctor to catch medicine” are in place. Although there is a flow of large medicinal materials in history, the original medicinal materials and slices do not have obvious distinction and boundaries, and the circulation of the market economy era has increased. In order to prevent the deterioration of medicinal materials, there is the division and distinction between the original medicinal materials and the slices, and and the distinction between the original medicinal materials and the slices, and it is also distinguished. Gradually be artificially separated into two independent processing systems.

3. Place of origin processing and processing processing cannot be divided into

The preliminary processing of Chinese medicinal materials and the processing of traditional Chinese medicine drinks are closely linked. For some Chinese medicinal materials, there is no clear division of labor between the two. The processing of traditional Chinese medicinal materials is not only increased production costs, but also the medicinal materials are stored and transported in storage and transportation. The deterioration loss and composition loss in the process will affect the quality of the drink.

Many Chinese medicines can be processed into drinks directly in the origin, some can be cut fresh and then dried, and some can be dry until the suitable water content is cut.

Ren Yuzhen, the chairman of the Chinese Medicine Association of Chinese Medicine Association, said: “The 2015 Chinese Pharmacopoeia edition has 64 varieties of production processing, such as dry ginger and yam. “,”

In “The Protection and Development Plan of Chinese Medicinal Materials 2015-2020”, it is clearly proposed to vigorously develop the origin of the origin “cutting and deep processing.” The author believes that Chinese medicinal materials are directly processed into drinking slices in the place of origin, which is in line with the development trend of the Chinese medicine industry, and the range of breeding should gradually expand while fresh processing.

How to solve the problem?

Chinese medicinal materials are directly processed into drinks (the integration of production area processing and GMP), which is in line with the development trend of the Chinese medicine industry. It will be a good way to change the current embarrassing situation of the Chinese medicine industry. Safe, assured, effective Chinese medicinal materials.

1. The advantage of the integration of production area processing and drinking films

Xiao Yongqing, chief researcher of the Chinese Academy of Traditional Chinese Medicine and the Director of the Quality Guarantee Specialty Committee of the Chinese Medicine Association of China, believes: “The source of the source of Chinese medicinal materials is the top priority of the quality of Chinese medicinal materials.”

The integration of the processing of traditional Chinese medicinal materials and the production of beverage films is actually to move the front of the drinking plant to the main producing area of ​​the authentic medicinal material, and it is clear that only one or several local authentic medicinal materials are processed. Its advantage is:

A. Only processed one local authentic medicinal material. Machinery processing equipment and quality inspection equipment have less investment, low risk, and high return.

B. Integrated, it can reduce the long -term moisturizing, soaking, and repeated drying of processing and processing, avoid the loss of ineffective ingredients and content, and reduce urban industrial waste;

C. Integration can effectively avoid many duplicate links in processing, reduce the loss of medicinal materials, human and energy waste, reduce losses and cost, and improve production efficiency and economic benefits;

D. Integrated, it ensures the source of medicinal materials and the quality of drinks, while it is conducive to traceability tracking and classification;

The integration of integration can combine the production specifications of traditional Chinese medicinal materials with the production specifications of decoction, which is conducive to the formation of the quality of medicinal materials to ensure the quality and clinical efficacy of Chinese medicine decoction tablets, thereby improving the good social image of the Chinese medicine industry.

The integration of the processing of Chinese medicinal materials and the production of slices can not only reduce processing costs, but also ensure the source, facilitate supervision, and help people eat safe, assured and effective Chinese medicinal materials. Xiao Yongqing, chief researcher of the Chinese Academy of Traditional Chinese Medicine and the Director of the Quality Guarantee Specialty Committee of the Chinese Medicine Association of China, also suggested that it is semi -finished in Chinese medicine drinking tablets that are allowed to be processed by the place where the origin allows the origin to be processed by fresh processing.

1. Actively promote integration

The law of the market is: who has good quality, low cost, and who is efficient, who can win, survive and continue. Anyone who can survive must have their own reasons and space. What exists is reasonable. Large -scale production of beverage processing is real.

The current reality is that some traditional Chinese medicine beverage factories only produce several or dozens of drinks, which have become sub -packaging companies for farmers processing slices. The processing machinery of their drinking pieces has become a decoration, and the production area processing is integrated with the production of slices. The source guarantees the quality of medicinal materials, and it can also solve the embarrassing situation of the current processing of Chinese medicinal materials, that is, it is convenient to trace the source and facilitate national supervision.

2. How can it be landed

Construct a group of single varieties and regional drinking factories in the main producing area of ​​authentic medicinal materials to improve the current circulation model. Through the “Internet+” concentration and diversion of the “Internet+” through Chinese herbal medicine storage and logistics bases, the national unified distribution and one -stop direct reach.

Single -breed beverage factory: It is a drinking factory with only one or several varieties. For example, the “Dangshen Drinking Factory” and “Angelica Drinking Factory”, which only produce a single variety in Gansu; build the “Chuanxiong Drinking Factory” and “Zexie Beverage Factory” in Sichuan; “Ginseng Drink Factory” and so on.

Regional drinking factory: It is a characteristic drinking factory in a certain area. For example, Huaizhong Drink Factory only produces four major pills, as well as Pan Wuwei, Jianliuwei, and Hunan Jiuwei. Each factory only produces several local medicinal materials.

3. Grasp the big varieties and form the quality of quality

Demand -oriented, survive with quality, and form a quality forced mechanism through traceability. Hundreds of Chinese medicinal materials with more than 1,000 tons are set up, and more than 1,000 single varieties and regional drinking paddles can be set up to meet the needs. Each beverage factory only produces and processes the authentic varieties of processing and processing, and the processing volume of one variety is large to do it. Cooperatives jointly build planting bases, and guide planting and initial processing to improve traceability data. The author believes that this can realize the scale of varieties and fine quality, provide accurate, detailed and real quality data for the country, and ensure quality and medication safety. Most of the production costs of single varieties are lower than the current multi -variety production costs. Products with good quality and low price of production areas will be welcomed by society, which will help reduce medical insurance expenses. The people benefit from the people.

Figure 7. The author should settle in the main origin of the authentic medicinal materials for these professional equipment

Fourth, conclusion

As the saying goes, “The shoes are not fit, only the feet know.” The author believes that if the “foot” of traditional Chinese medicine puts on the “westernized” pair of “shoes”, it will constantly “cut the foot to achieve”. How to do “shoes” is determined by the people wearing, and the shoes that don’t understand the feet are shackles. In fact, shoes are not suitable, and shoes need to be changed instead of surgery for foot. Only by creating a “shoes” for Chinese medicine, the footsteps of Chinese medicine can keep up with the times.

If the chemical component is completely used to determine and quantitative Chinese medicine, it is not appropriate to bring Chinese medicine into a dead alley.

At present, the “Drug Management Law” is being amended in an all -round way, and it is planned to cancel the certification of GSP (drug management quality management specifications) and GMP (drug production quality management specifications) for pharmaceutical companies. In response to this change, Yu Zhibin, director of the Chinese Medicine Department of the China Medical and Health Products Import and Export Chamber of Commerce, believes: “The competent industry department of the industry should actively change its functions, strengthen supervision during the matter, chase afterwards, and form full supervision.”

5. Suggestions

At present, the origin of Chinese medicinal materials is relatively concentrated, and the advantages of authentic medicinal materials are prominent. With the degradation of market functions and the formation of “Internet+”, the process of processing place processing and GMP integration must be accelerated. The integration of initial processing and drinking slices in the origin of the place of origin is more guaranteed to the quality of medicinal materials, reducing secondary soaking and loss of composition. The transportation costs, labor costs, and urban waste of Chinese medicinal materials will be greatly reduced. The essence and characteristics of traditional Chinese medicine, the national policy of reform and opening up and the supply -side reform of traditional Chinese medicine, is beneficial to the development of the Chinese medicinal materials industry.

To this end, the author recommends: examine the adaptability of the processing of Chinese medicine drinking films and GMP certification, redefine the processing of Chinese medicinal materials, and actively promote the integration of production area processing and drinking films processing!

In the next article, we will discuss “My Cognition and Suggestion of Trace of Chinese Medicinal Materials”, so stay tuned.

Liu Hongwei 2019.2.25

about the author

Liu Hongwei, senior information and resource experts of Chinese medicinal materials, pioneers of Chinese medicinal materials information, and the core history of Tiandi.com. Former manager, secretary, secretary of the Henan Province Sanmenxia Medicine Station, Vice President of Henan Provincial Traditional Chinese Medicine Industry Association, supervisors of the board of directors of Chengdu Tiandi Network Information Department, Director of Expert Committee, and senior adviser. At the age of 65, a member of the Communist Party of China and retired cadres. He has been engaged in Chinese medicinal materials for more than 40 years, and has traveled to 30 provinces and municipalities and autonomous regions across the country. He has inspected more than 200 medicinal materials and real estate land. For decades, more than 3 million words of manuscripts have been published in the national medicinal materials information magazines, newspapers, journals, online magazines, and the Internet.

Social part -time job:

Deputy Chairman of the National Chinese Medicinal Materials Logistics Expert Committee

Vice Chairman of the Chinese Medicine Association of Chinese Medicine Association of Traditional Chinese Medicine

Member of the Expert Committee of the Chinese Medicine Resources Branch of Chinese Medicine Traditional Chinese Medicine

Expert Member of the Professional Committee of Traditional Chinese Medicine Materials Planting and Cultivation of Chinese Medicine Association

A member of the first expert committee of the standardized production committee of the Chinese herbal medicine base for the co -construction of the shared alliance.

In order to answer your doubts, the above is what we have organized about “Chromatography Separating Automatic Equipment for Herbal Chinese Medicine “, hope it can help you.